MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MITRIS RESILIA MITRAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11400M

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Laceration(s) (1946)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

Valve explant at implant is typically a result of inappropriate sizing, difficulty seating, distortion of the valve, valve displacement before/after frame expansion, and/or the patients anatomy, and not a malfunction of the device.There may be cases in which regurgitation is detected by tee prior to the completion of the surgical case and exchange of the valve is required.The device was not returned for evaluation, as the device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that a 25 mm mitral valve was explanted at implant due to oversizing.A non-edwards valve was implanted.The patient was doing fine.As reported, the valve was placed intra-annular with everting sutures.The p1 area had chunks of calcium that could not be removed.After the surgeon placed all the sutures through the cuff, he realized that the valve was too big.There was a lot of blood and had trouble seeing his pledgets in the area of p1.The annulus was ripped and was ultimately repaired with a bovine pericardial patch.The surgeon mentioned after the fact that when he sized with the barrel end it was a bit tight, but he felt the valve could fit in.There were not any complaints about the actual valve.The surgeon used the replica sizers.

Manufacturer Narrative

Product evaluation: customer report of sizing issues was unable to be confirmed.X-ray demonstrated wireform intact.The external sewing ring diameter measured to be approximately 36 mm and the internal stent diameter measured to be approximately 25 mm.Suture holes were visible around the sewing ring.No visible inconsistencies were observed from the returned valve.

Manufacturer Narrative

H10: additional narratives: updated d4, h4, and h6 per new information received.The most likely cause is procedural factors, including the surgeon mentioned after the fact that when he sized with the barrel end it was a bit tight, but he felt the valve could fit in.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EDWARDS MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14622654
• MDR Text Key: 293538813
• Report Number: 2015691-2022-06087
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103205534
• UDI-Public: (01)00690103205534(17)240203(11)220203218688843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 11400M
• Device Catalogue Number: 11400M25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Female